Recall Z-2086-2016 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Integra LifeSciences Corp.
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
| Date | Apr 29, 2016 |
| Status | Terminated |
| Reason | As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium. |
| Root cause | Labeling mix-ups |
| Action | On 4/29/16, US consignees were notified by electronic mail delivered by traceable method. |
| Quantity | 12 units |
| Distribution | NC and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151459 | Integra Total Ankle Replacement System Ascension Orthopedics, Aug 31, 2015 |